Bioequivalence and Bioavailability Forum • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence

Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence [BE/BA News]

posted by SMA – Europe, 2023-02-06 10:07 (830 d 18:12 ago) – Posting: # 23439
Views: 7,939

Good morning all

FDA is organizing a webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence

Agenda

March 14, 2023
10:00 AM - 12:00 PM US ET

TOPICS COVERED
In Vitro Bioequivalence assessment
Statistical Methods for Narrow Therapeutic Index and Highly Variable Drug Products
Comparative Clinical Endpoint Bioequivalence Studies
Studies in Multiple Groups
Bioequivalence Statistics for Adhesion and Irritation Studies
Dose Scale for Bioequivalence Assessment

Complete thread:

New guidance on Statistical Approaches to Establishing Bioequivalence Relaxation 2022-12-02 15:53
- A first look Helmut 2022-12-02 16:43
  - A first look jag009 2022-12-02 17:58
    - A first look BRB 2022-12-02 18:20
  - SAS strikes back mittyri 2022-12-02 20:38
    - SAS strikes back Helmut 2022-12-02 22:30
      - Outliers? mittyri 2022-12-02 22:52
        
        Outliers? Helmut 2022-12-02 23:11
      - SAS strikes back Achievwin 2023-02-07 07:23
  - model-based BE? mittyri 2022-12-07 16:26
    - model-based BE? Helmut 2022-12-10 10:13
      - Hooker, Moellenhoff et al. are moving MBBE forward mittyri 2023-01-11 15:32
      - model-based BE? SMA 2023-01-17 09:41
  - A first look PharmCat 2022-12-21 19:30
  - A first look Rayhope 2023-01-06 06:56
- Groups, sites… Helmut 2022-12-03 13:09
- SxF ElMaestro 2022-12-04 06:34
  - SxF Helmut 2022-12-10 10:37
- New guidance on Statistical Approaches to Establishing Bioequivalence Mahmoud 2022-12-10 14:08
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing BioequivalenceSMA 2023-02-06 09:07
  - Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13
    - Multi-group studies ad nauseam Helmut 2023-02-07 11:30
      - Multi-group studies ad nauseam Achievwin 2023-02-25 16:18
    - Webinar: Recording available Helmut 2023-04-01 10:38
  - Speed kills Helmut 2023-02-07 13:02